FDA Product Code MQB: Solid State X-ray Imager (flat Panel/digital Imager)
FDA product code MQB covers solid-state X-ray imagers, also known as flat panel detectors or digital image receptors.
These devices replace traditional film and computed radiography cassettes with direct digital capture of X-ray images. They provide higher image quality, lower radiation dose, and immediate image availability compared to conventional systems.
MQB devices are Class II medical devices, regulated under 21 CFR 892.1680 and reviewed by the FDA Radiology panel.
Leading manufacturers include Iray Technology Taicang , Ltd., Canon, Inc. and DRTECH Corporation.
421
Total
421
Cleared
80d
Avg days
1997
Since
421 devices
Cleared
Feb 03, 2023
Digital Flat Panel Detector
Ray Imaging Technology (Haining) Limited
Radiology
25d
Cleared
Jan 27, 2023
14HQ721G-B
Lg Electronics.Inc
Radiology
63d
Cleared
Dec 30, 2022
X-ray Flat Panel Detectors (EverestView 4343X)
Careray Digital Medical Technology Co., Ltd.
Radiology
21d
Cleared
Nov 27, 2022
Wireless/Wired X-Ray Flat Panel Detectors
Allengers Medical Systems Limited
Radiology
59d
Cleared
Nov 18, 2022
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
DRTECH Corporation
Radiology
46d
Cleared
Nov 17, 2022
SKR 3000
Konica Minolta, Inc.
Radiology
24d
Cleared
Oct 20, 2022
Mercu 1717V
Iray Technology Taicang , Ltd.
Radiology
27d
Cleared
Oct 17, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
Canon, Inc.
Radiology
26d
Cleared
Sep 29, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
Canon, Inc.
Radiology
23d
Cleared
Sep 27, 2022
Digital Radiography CXDI-CS01
Canon, Inc.
Radiology
25d
Cleared
Sep 13, 2022
Solid State X-ray Imager(Model: FXRD-4386WB)
Vieworks Co., Ltd.
Radiology
228d
Cleared
Aug 01, 2022
X-ray Flat Panel Detectors (CareView 1800 RF)
Careray Digital Medical Technology Co., Ltd.
Radiology
62d
Cleared
Jul 22, 2022
14HQ701G-B
Lg Electronics.Inc
Radiology
70d
Cleared
Jul 22, 2022
10HQ701G-B
Lg Electronics.Inc
Radiology
64d
Cleared
Jul 20, 2022
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
Vieworks Co., Ltd.
Radiology
57d
Cleared
Jul 15, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
Canon, Inc.
Radiology
17d
Cleared
Jul 13, 2022
17HQ701G-B
Lg Electronics.Inc
Radiology
57d
Cleared
Jun 29, 2022
Flat Panel Detector
Iray Technology Taicang , Ltd.
Radiology
16d
Cleared
Jun 16, 2022
Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Radiology
38d
Cleared
Jun 14, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
Canon, Inc.
Radiology
11d
Cleared
May 13, 2022
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
Radisen Co., Ltd.
Radiology
23d
Cleared
May 05, 2022
17HQ901G-B
Lg Electronics.Inc
Radiology
66d
Cleared
Apr 28, 2022
Digital flat panel detector
Iray Technology Taicang , Ltd.
Radiology
63d
Cleared
Apr 14, 2022
Yushan X-Ray Flat Panel Detector with DROC
Innocare Optoelectronics Corp.
Radiology
51d